Freedom of Information request on the safety and efficacy of COVID-19 vaccines (FOI 22/437)
Published 31 May 2022
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FOI 22/437
21st February 2022
Dear
Thank you for your email.
Please find below answers to the questions you raise.
1, Evidence that the Covid-19 vaccine has a efficacy rate of higher than 2%.
The safety and efficacy of the authorised vaccines in the clinical trials is available in the Public Assessment Reports that have been published by MHRA and the European Medicines Agency (EMA). Links to these are provided below:
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna
https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty
https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-moderna
https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca
2, It is safe for use in the general public with less than 10 deaths per million doses and minimal adverse reactions.
Please see our response above and the links to the PARs.
All medicinal products are assessed by MHRA to ensure that there is a positive benefit-risk before they are given a marketing authorisation. MHRA continually monitors the safety of medicines and vaccines during widespread use, and we have in place a proactive strategy to do this for COVID-19 vaccines. Through this strategy we are able to rapidly detect, confirm, and quantify any new risks and weigh these against the expected benefits. We can then take any necessary action to minimise risks to individuals. We also work closely with our public health partners in reviewing the effectiveness and impact of the vaccines to ensure the benefits continue to outweigh any possible side effects. It is important to note that vaccination is the single most effective way to reduce deaths and severe illness from COVID-19. All vaccines and medicines have some side effects. These side effects need to be continuously balanced against the expected benefits in preventing illness. Following widespread use of these vaccines across the UK, the vast majority of suspected Adverse Drug Reaction (ADR) reports so far confirm the safety profile seen in clinical trials. Please be assured that should any safety concerns be identified during routine pharmacovigilance activities, these will be communicated to the patients and healthcare professionals alike with the upmost importance.
3, Scientific evidence and proof that the Covid-19 virus exists, has been isolated, and has directly killed more than 100 people worldwide.
MHRA holds no information on the isolation of the Covid-19 virus. We suggest that you consult the Scientific Advisory Group for Emergencies (SAGE) website. A link to this is provided below:
https://www.gov.uk/government/organisations/scientific-advisory-group-for-emergencies
The SAGE website includes information supporting the government’s’ decision-making on the Covid-19 pandemic, including information on the isolation of the Covid-19 virus.
Please note that information on the isolation of the Covid-19 virus is also available in the public domain through scientific papers.
4, The numbers or alleged deaths 'from Covid-19' where Midazolam had been prescribed or administered prior to the recipient passing away.
This is information we do not hold. We suggest you contact Office for National Statistics and Public Health England.
Contact us - Office for National Statistics (ons.gov.uk)
https://www.gov.uk/government/organisations/public-health-england
5, The number people in England that have received >5mg of Midazolam within a 24hr period in the past 2 years and their current life status. ie Are they now dead or still alive.
The same as above.
6, Any evidence that your vaccine has saved more lives than it has taken.
NHS responded to customer providing information the UK Health Security Agency (UKHSA) estimated that, as of 24 September 2021, 127,500 deaths and 24,144,000 infections had been prevented because of the COVID-19 vaccine.
7, Why you feel it necessary to push a genocidal medication without fully informed consent prior to its trial period completing and many years (50+) before the full trail data is available to the public.
We have provided links to the PARs that MHRA and the EMA have published, to show why these vaccines have been authorised.
In addition, the clinical data for the authorised vaccines, has been published and can be accessed via the link below:
https://clinicaldata.ema.europa.eu/web/cdp/home
The main efficacy and safety results for the Phase I, II and III trials for all authorised vaccines have been submitted to MHRA, sufficient that these vaccines can be authorised for use in the patient populations stated in the Information for Healthcare Professionals/Summary of Product Characteristics for each vaccine. These studies are currently ongoing to follow-up vaccine recipients to collect additional safety data, in the same way that all clinical trials for new medicines follow up their study subjects after the main results of the study have been reported. Other studies that are currently in progress are to investigate the use of vaccine outside of the current authorisations (such as giving different brands of vaccine for the first and second doses).
The estimated dates for the end of completion of the clinical trials are as follows:
AstraZeneca Phase I/II Estimated Study Completion Date: November 15, 2021 https://clinicaltrials.gov/ct2/show/NCT04568031
AstraZeneca Phase III Estimated Study Completion Date: February 14, 2023 https://clinicaltrials.gov/ct2/show/NCT04516746
Pfizer/BioNTech PHASE 1/2/3, Estimated Study Completion Date: April 6, 2023 https://clinicaltrials.gov/ct2/show/NCT04368728
Moderna Phase 2a Estimated Study Completion Date: November 1, 2021 https://clinicaltrials.gov/ct2/show/NCT04405076
Moderna Phase 3 Estimated Study Completion Date: October 27, 2022 https://clinicaltrials.gov/ct2/show/NCT04470427
8, Who is liable for any adverse reactions or death caused by this vaccine?
Regarding your questions about civil liability and immunity, information on this is available to view at the following link of our website page below:
https://www.gov.uk/government/consultations/distributing-vaccines-and-treatments-for-covid-19-and-flu/consultation-document-changes-to-human-medicine-regulations-to-support-the-rollout-of-covid-19-vaccines#civil-liability-and-immunity
Any further enquiries concerning liability should be sent to the Department of Health and Social Care (DHSC).
9, That lockdowns and masks have any significant affect on preventing transmission of this virus.
MHRA holds no information on the effectiveness of lockdowns and mask wearing on the prevention of transmission of the Covid-19 virus.
10, That the human immune system will not be compromised after receiving a vaccine.
The MHRA collect reports of suspected adverse reactions to all medicines and vaccines via the Yellow Card scheme. All reports are continually reviewed to detect possible new side effects that may require regulatory action, and to differentiate these from things that would have happened regardless of the vaccine or medicine being administered, for instance due to underlying or undiagnosed illness.
Since the launch of the COVID-19 immunisation campaign we have been proactively monitoring the safety of all approved COVID-19 vaccines for near real-time safety monitoring at population level. Our adverse reaction assessment report can be found here: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions
Throughout this global pandemic, we have always been guided by the latest scientific advice. Having studied evidence on both the Pfizer/BioNTech and Oxford/AstraZeneca vaccines, the Joint Committee on Vaccination and Immunisation (JCVI) has advised that we should prioritise giving as many people in at-risk groups their first dose, rather than providing two doses in as short a time as possible.
The four UK Chief Medical Officers agree with JCVI that at this stage of the pandemic prioritising the first doses of vaccine for as many people as possible on the priority list will protect the greatest number of at risk people overall in the shortest possible time and will have the greatest impact on reducing mortality, severe disease and hospitalisations and in protecting the NHS and equivalent health services.
This is because the evidence shows that one dose of either vaccine provides a high level of protection from Covid-19.
For both vaccines, data provided to MHRA demonstrate that whilst efficacy is optimised when a second dose is administered both offer considerable protection after a single dose, at least in the short term. For both vaccines the second dose completes the course and is likely to be important for longer term protection.
The NHS across the UK will prioritise giving the first dose of the vaccine to those in the most high-risk groups. Everyone will still receive their second dose and this will be within 12 weeks of their first. The second dose completes the course and is important for longer-term protection.
The JCVI’s independent advice is that this approach will maximise the benefits of both vaccines allowing the NHS to help the greatest number of people in the shortest possible time. It will ensure that more at-risk people are able to get meaningful protection from a vaccine in the coming weeks and months, reducing deaths and starting to ease pressure on our NHS.
For further information on prioritising the first COVID-19 vaccine dose see the statement from the Joint Committee on Vaccination and Immunisation (JCVI). This information includes the rationale and evidence for prioritising the first dose.
The following link provides information on Covid-19 Booster programme.
11, That there is not an increase chance of suffering from a short illness prior to death after receiving your Covid-19 vaccines.
For all COVID-19 vaccines, the overwhelming majority of Adverse Drug Reaction (ADR) reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as ‘flu-like’ illness, headache, chills, fatigue (tiredness), nausea (feeling sick), fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these happen shortly after the vaccination and are not associated with more serious or lasting illness.
These types of reactions reflect the normal immune response triggered by the body to the vaccines. They are typically seen with most types of vaccine and tend to resolve within a day or two. The nature of reported suspected side effects is broadly similar across age groups, although, as was seen in clinical trials and as is usually seen with other vaccines, they may be reported more frequently in younger adults.
Vaccination and surveillance of large populations means that, by chance, some people will experience and report a new illness or events in the days and weeks after vaccination. A high proportion of people vaccinated early in the vaccination campaign were very elderly, and/or had pre-existing medical conditions. Older age and chronic underlying illnesses make it more likely that coincidental adverse events will occur, especially given the millions of people vaccinated. It is therefore important that we carefully review these reports to distinguish possible side effects from illness that would have occurred irrespective of vaccination. The majority of the ADR reports with a fatal outcome that we have received were in elderly people or people with underlying illness. Usage of the vaccines has increased over the course of the campaigns and as such, so has reporting of fatal events with a temporal association with vaccination. However, this does not mean that there is a link between vaccination and the fatalities reported. Review of specific fatal reports is provided within our weekly summary of Yellow Card reporting . The pattern of reporting for all other fatal reports does not suggest the vaccines played a role in these deaths.
The expected benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects. As with all vaccines and medicines, the safety of COVID-19 vaccines is continuously monitored and benefits and possible risks remain under review.
12, A list of deaths correlation to vaccine batch numbers.
This information would be exempt from release under Section 41 of the FOI Act (Information provided in confidence) We would not provide any details about individual deaths and its important that we protect their confidentiality.
If you have a query about the information provided, please reply to this email.
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Yours sincerely
MHRA Customer Experience Centre